Label: AMBRISENTAN tablet, film coated

  • NDC Code(s): 70771-1363-1, 70771-1363-3, 70771-1363-7, 70771-1363-8, view more
    70771-1363-9, 70771-1364-1, 70771-1364-3, 70771-1364-7, 70771-1364-8, 70771-1364-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 19, 2023

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1363-3

    Ambrisentan Tablets, 5 mg

    30 Tablets

    Rx only

    labels

    NDC 70771-1364-3

    Ambrisentan Tablets, 10 mg

    30 Tablets

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    AMBRISENTAN 
    ambrisentan tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1363
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMBRISENTAN (UNII: HW6NV07QEC) (AMBRISENTAN - UNII:HW6NV07QEC) AMBRISENTAN5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 1179
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1363-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    2NDC:70771-1363-990 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    3NDC:70771-1363-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    4NDC:70771-1363-83 in 1 CARTON04/12/2019
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:70771-1363-71 in 1 CARTON04/12/2019
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21005804/12/2019
    AMBRISENTAN 
    ambrisentan tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1364
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMBRISENTAN (UNII: HW6NV07QEC) (AMBRISENTAN - UNII:HW6NV07QEC) AMBRISENTAN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorWHITE (OFF WHITE) Scoreno score
    ShapeOVAL (OVAL) Size10mm
    FlavorImprint Code 1180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1364-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    2NDC:70771-1364-990 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    3NDC:70771-1364-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    4NDC:70771-1364-83 in 1 CARTON04/12/2019
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:70771-1364-71 in 1 CARTON04/12/2019
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21005804/12/2019
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1363, 70771-1364) , MANUFACTURE(70771-1363, 70771-1364)
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